The Business Cocktail

AstraZeneca slapped with second Complete Response Letter

Having a potential blockbuster sidelined because of manufacturing issues is bad enough, but AstraZeneca has now had that experience twice—both times receiving a complete response letter from the FDA. For a second time, AstraZeneca has received a complete response letter tied to the manufacturing of the hyperkalemia treatment, a potential blockbuster treatment that was the target of AstraZeneca’s $2.7 billion buyout of ZS Pharma in 2015. Since getting its first CRL for the drug in May 2016, AstraZeneca has been joined by a number of other drug makers that have had drug launches sidelined by manufacturing problems. Among those are Sanofi and Regeneron, which in October were issued a CRL for sarilumab, a candidate for the treatment of rheumatoid arthritis that has also been predicted to hit blockbuster numbers. The CRL was issued because of a long list of deficiencies at a Sanofi fill-finish plant in Le Trait, France.

Patheon says buyout of Roche API plant gives it border tax protection

Jim Mullen, CEO of CDMO Patheon, said the company and its clients are wondering what the Trump administration’s tax proposals will mean for them but if a border tax were to be imposed, its $1 million pickup of a former Roche API plant in the U.S. puts it good shape to face it. The tax discussion came after the contractor reported first-quarter 2017 earnings in which revenue was up 13% to $457 million and EPS on continuing operations was $0.19 a share. The company also guided lower for 2017, saying that some expected contracts had shifted and revenue from them would be realized in 2018. With the buyout last quarter of a Roche API plant in Florence, South Carolina, the company now has API sites there and in Greenville, North Carolina, and development activities in South Carolina and Europe, creating a 50-50 split between the two markets.

The last time Sanofi and Regeneron launched a drug together, Amgen sued for patent infringement. Now, with an FDA decision on their key drug Dupixent due next week, the development partners are making a pre-emptive strike in patent court. Sanofi and Regeneron sued Amgen on Monday, seeking a declaration that Dupixent, also known as dupilumab, does not infringe on a particular Amgen patent. The companies say they don’t believe Dupixent steps on Amgen’s intellectual property but want a court back that up. The lawsuit, filed in U.S. District Court in Boston, asks a judge to determine that the two companies don’t infringe on Amgen’s ‘487 patent, which cites IL-4 and IL-13 antibodies. Dupixent is a drug targeted at IL-4 and IL-13, two immune system pathways implicated in allergic diseases.

Cerulean Pharma Inc. and Daré Bioscience, Inc., a privately-held, clinical-stage pharmaceutical company advancing products for women’s reproductive health, announced that the two companies, together with the equity holders of Daré Bioscience, have entered into a definitive stock purchase agreement under which the equity holders of Daré Bioscience will become the majority owners of Cerulean. The transaction and the Cerulean asset sales would result in a NASDAQ-listed company with a focus on the development and commercialization of products for women’s reproductive health. Daré Bioscience’s product candidate, Ovaprene®, is a clinical stage, non-hormonal contraceptive ring for monthly use that potentially addresses a significant unmet need. Contraception is a $16 billion global market. However, since the approval of the birth control pill by the FDA in 1960, most innovation has focused on hormones.

Eli Lilly says it’s cutting an average of 50% off list prices—and its price hikes don’t work

Heightened pressure from pharmacy benefit managers and increased competition among drugmakers are taking a big bite out of Eli Lilly’s list-price hikes—an 11-percentage-point bite, on average, the company said in a new report. After raising list prices an average of 14% in 2016, and wheeling and dealing with payers, Eli Lilly netted an overall price increase of 2.4%, the company said in a new report. That’s a major comedown from 2015, when a 16.3% average increase yielded a net rise of 9.4%. Lilly joined pharma peers Johnson & Johnson and Merck in unveiling its high-level pricing data, as part of a summary of its annual report. On average, the company says discounts have grown to 50% over the last 5 years, up from 28% in 2012.